Eisner Safety Consultants

FDA Formally Recognized AAMI ES60601-1:2005 (National Version of IEC60601-1:2005 = 3rd edition) as Consensus Standard on 6/10/10.  The transition period indicated on the FDA Consensus Standard web page for AAMI/ANSI ES 60601-1:2005 says in summary that 2nd edition of IEC 60601-1 will be accepted until June 30,2013 and after that only ANSI/AAMI ES60601-1:2005 will be [...]

Joint FDA/FCC public meeting July 26  & 27, 2010 – Enabling Convergence of Communication & Medical Systems: Update Regulatory & Info Processes http://ht.ly/20oMz
Summary:  The FDA and the FCC are jointly sponsoring a public meeting entitled “Enabling the Convergence of Communications and Medical Systems: Ways to Update Regulatory and Information Processes.”

Comment on Draft Guidance for Industry, 3rd Parties & FDA Staff: ISO 13485:2003 Voluntary Audit Rprt Submission Program http://ht.ly/1OeVB

Follow FDA CDRH (Device Info & CDRH Industry) on Twitter http://ht.ly/1Lc7D
Available Twitters as of May 14, 2010

FDADeviceInfo – Information and news on device recalls, other safety issues, approvals, and other device and radiation-emitting product topics.
FDAcdrhIndustry – Helpful links, information, and news for industry related to medical device and radiation-emitting products.

FDA establishes a Home Use Devices Web PAge – Repository of Info on FDA perspective for Home Use Med Dvcs http://ow.ly/1El0q